BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2232981 · Received July 20, 2011

    Report

    Report Number
    3008642652-2011-00266
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 5, 2011
    Manufacturer
    ZOLL LIFECOR CORP
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY/CHARGER FAULTS) HAS BEEN INVESTIGATED. UPON EVALUATION CORROSION WAS DISCOVERED ON THE BATTERY CONNECTOR. THE CAUSE OF THE CORROSION HAS NOT BEEN POSITIVELY DETERMINED BUT WAS LIKELY THE RESULT OF LIQUID INGRESS WITHIN THE BATTERY CONNECTOR WELL. DEVICE EVALUATION OF BATTERY PACK SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY/CHARGER FAULTS) HAS BEEN CONFIRMED. UPON EVALUATION THE BATTERY OUTPUT VOLTAGE WAS MEASURED AT 2.56V. THE CAUSE FOR THE DISCHARGED BATTERY PACK CANNOT BE POSITIVELY DETERMINED BUT WAS LIKELY ASSOCIATED WITH THE DEFECTIVE CHARGER. NO ADVERSE EVENT RESULTED FORM THE DEFECTIVE BATTERY CHARGER/MODEM AND BATTERY PACK. THE PT WAS ISSUED REPLACEMENT EQUIPMENT. DEVICE MANUFACTURE DATE: BATTERY CHARGER/MODEM SN (B)(4): 10/2009, BATTERY PACK SN (B)(4): 03/2009.

    Description of Event or Problem · 1

    THE WIFE OF A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PT'S BATTERIES WILL NOT CHARGE ON THE CHARGER. THE PT WAS ISSUED TWO REPLACEMENT BATTERIES AND A REPLACEMENT BATTERY CHARGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR